Prevention of incisional hernias with prophylactic synthetic mesh placement during stoma reversal
Recruiting
- Conditions
- Stoma, incisional hernia.
- Registration Number
- NL-OMON27268
- Lead Sponsor
- o sponsoring
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
> 18 years
- Indication for colostomy or ileostomy reversal
Exclusion Criteria
- Intraperitoneal dialysis
- Connective tissue disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incisional hernia at stoma closure site at 1-year follow up, as seen on CT or abdominal ultrasound.
- Secondary Outcome Measures
Name Time Method - Clinical diagnosis of incisional hernia at 1-year follow up<br /><br>- Number of patients requiring surgical intervention for correction of incisional hernia<br /><br>- 30-day morbidity<br /><br>- 30-day mortality<br /><br>- 30-day readmission and re-operation rate<br /><br>- QoL (SF-36, EQ5-D)<br /><br>- Hernia related Quality of life (HerQLes)<br /><br>- Cost effectiveness (iPCQ, iMCQ)